Drug ID: 1d00000054
Drug Name: Aliskiren and valsartan
Generic Names: Valturna
Category: Anti- Hypertensives
Legal Status: Non Opioid Prescription only drug
Indication for Mother: Category D
There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Recommended Dose: The recommended dose is 150/160 mg or 300/320 mg once daily.
Maximum: 300/320 mg.
Recommended In: This combination medication contains renin inhibitor and angiotensin II receptor blocker, prescribed for high blood pressure either alone or with other medications.
Directions For Use: It comes as a tablet to take by mouth, with or without food.
Storage: Store it at room temperature (25°C).
Dosage Forms: Tablet
Side Effects: Most Common - Shock and low blood pressure.
Genitourinary - Bladder pain, bloody or cloudy urine, painful urination and urine urgency.
Respiratory - Cough, difficulty in breathing, runny nose, nasal congestion and sneezing.
General - Body pain, chills, fever, shivering, general discomfort, headache, and tiredness.
Gastrointestinal - Diarrhea, loss of appetite, nausea and vomiting.
ENT - Ear congestion and loss of voice.
Musculoskeletal - Joint pain, lower back pain and muscle pain.
In Case of Overdose: Aliskiren
Limited data are available related to overdosage in humans. The most likely manifestation of overdosage would be hypotension. If symptomatic hypotension occurs, provide supportive treatment.
Aliskiren is poorly dialyzed. Therefore, hemodialysis is not adequate to treat aliskiren overexposure.
Limited data are available related to overdosage in humans. The most likely effect of overdose with valsartan would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. Depressed level of consciousness, circulatory collapse and shock have been reported. If symptomatic hypotension occurs, provide supportive treatment.
Valsartan is not removed from the plasma by hemodialysis.
Avoid If: Caution should be exercised in patients with history of blood vessel problems, blood flow problems, heart, liver, kidney disease, gout, gallbladder problems, sugar, stroke, recent heart attack, dehydration, low blood volume, severe allergic reactions, during pregnancy and breastfeeding.
It may cause drowsiness, dizziness, or blurred vision, do not drive a car or operate machinery and get up slowly from bed while taking this medication.
It may cause a serious side effect called angioedema with the following symptoms: swelling in the face, ear, neck etc; breathing trouble, fever, difficulty in swallowing, and shock. If it is so consult with your doctor.
Monitor blood pressure, blood electrolyte levels, heart, kidney, and liver functions regularly while taking this medication.
It should not be used in children.
Contraindicated in pregnant women and in patients with known hypersensitivity.
Drug Interaction: Aliskiren
Cyclosporine: Avoid co-administration of cyclosporine with aliskiren.
Itraconazole: Avoid co-administration of itraconazole with aliskiren.
CYP 450 Interactions: In vitro metabolism studies have indicated that CYP450 mediated drug interactions between valsartan and coadministered drugs are unlikely because of low extent of metabolism.
Transporters: The results from an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1 and the hepatic efflux transporter MRP2. Coadministration of inhibitors of the uptake transporter (rifampin, cyclosporine) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan.
As with other drugs that block angiotensin II or its effects, concomitant use of potassium sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine.
Aliskiren and Valsartan
Non-Steroidal Anti-Inflammatory Agents(NSAIDS) including selective Cyclooxygenase-2 inhibitors (COX-2 inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors with agents that affect the renin-angiotensin system, including aliskiren and valsartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving aliskiren, valsartan and NSAID therapy.
The antihypertensive effect may be attenuated by NSAIDS.